Associate Vice President (Avp), Clinical Data Management

Amgen

25+ years years

Not Disclosed

Hyderabad

10 Sept. 2, 2025

Job Description

Job Type: Full Time Education: Bachelor’s or Master’s Degree Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

✅ Job Title:

Associate Vice President (AVP), Clinical Data Management

🏢 Company:

Amgen

📍 Location:

Hyderabad, India
(On-site role)

📅 Date Posted:

August 11, 2025

🔢 Job ID:

R-222164

🧪 Job Category:

Clinical

🌍 Work Location Type:

On Site

🎯 About Amgen:

Since 1980, Amgen has been a pioneer in biotechnology, focused on serving patients suffering from serious illnesses. The company operates in four key therapeutic areas:

Oncology
Inflammation
General Medicine
Rare Disease

With millions of patients impacted annually, Amgen’s mission is to improve lives through innovative medicines and groundbreaking science.

🌐 Website: www.amgen.com

💼 Position Summary:

The Associate Vice President, Clinical Data Management (CDM) is a key member of the Global Development Operations (GDO) leadership team and a strategic partner to the R&D organization.

This leader is responsible for the strategic direction, leadership, and operational oversight of global data management processes across all clinical development programs and therapeutic areas.

🛠️ Key Responsibilities:

Strategy & Leadership:
- Develop and drive global CDM strategy aligned with Amgen’s clinical and corporate objectives.
- Lead innovation in data management including AI/ML technologies and digital health tools.
Operations & Execution:
- Ensure high-quality clinical data collection, processing, and analysis for regulatory submissions.
- Oversee CDM SOPs, best practices, data governance, and quality standards.
Collaboration & Representation:
- Act as the CDM lead during regulatory inspections and audits.
- Represent CDM in executive leadership meetings, regulatory bodies, and industry forums.
Risk Management & Compliance:
- Implement risk mitigation strategies and ensure compliance with global standards (GCP, ICH, FDA, EMA).
- Ensure readiness for inspections and drive a culture of continuous improvement.
Resource & Vendor Management:
- Optimize staffing, outsourcing strategies (e.g., FSP), and technology investments.
- Manage CROs, vendors, and cross-functional partnerships (Regulatory, Biostatistics, Clinical Ops).

📚 Basic Qualifications:

Bachelor’s or Master’s Degree
25+ years of experience in Clinical Data Management
10 to 15 years of leadership or managerial experience

🌟 Preferred Qualifications:

Deep knowledge of:
- GCP, ICH, CDISC, SDTM, ADaM, FDA/EMA regulations
- Data governance, audit readiness, and regulatory compliance
Expertise in:
- AI/ML, automation, digital trials, decentralized models
- Advanced analytics & clinical data standards
Proven leadership in:
- Large global teams, CRO/vendor partnerships, cross-functional collaboration
- Organizational change, process optimization, and lean implementation
Experience in:
- Regulatory submissions (NDA/BLA/MAA)
- Technology platforms (EDC, CTMS, RWD/RWE)

💡 Leadership Attributes:

Inspire: Build a connected, inclusive, and high-performing team culture
Accelerate: Act with urgency and drive results with focus on patients
Integrate: Collaborate across functions to maximize impact
Adapt: Embrace change and provide clarity in complex environments

🎁 What You Can Expect at Amgen:

A collaborative, science-driven culture
Opportunities to make a lasting impact on global health
Inclusive work environment with competitive benefits
Commitment to professional growth and well-being

♿ Equal Opportunity Employer:

Amgen is committed to diversity, equity, and inclusion. Reasonable accommodations will be provided for individuals with disabilities during the application, interview, and employment process.

📩 Application Process:

No deadline; applications accepted until the position is filled
Apply through Amgen Careers

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Associate Vice President (Avp), Clinical Data Management

Job Description

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